Objective To assess the effectiveness and safety of Shenling granule for lower urinary tract infection （damp-heat in lower-Jiao ） in comparison with Niaoganling Chongji. Methods A double-bhnd, double-dummy, randomized controlled trial was conducted. A total of 96 patients （damp-heat in lower-Jiao） were randomized to the treatment group （n =72, Shenling granule, 1 bag, rid） and the control group （n =24, Niaoganling Chongji, 1 bag, tid）. The therapeutic course for both groups was 1 week. Results ITT （intention-to-treatment） analysis showed that the total effective rates of the treatment group and the controlled group were 92.43% and 91.31% , respectively （P 〉0.05）. PP （perprotocol-population） analysis showed that they were 92.31% and 90.91% , respectively （ P 〉0.05 ）. The effective rates on Chinese medicine symptom of the treatment group and the controlled group were 93.43% and 95, 65% respectively by ITT analysis （ P 〉0.05 ） , 95.38% and 94.45% respectively by PP analysis （ P 〉0.05 ）, No significant difference between the two groups was detected. No adverse effect was found. Conclusions There is no significant difference between Shenling granule and Niaoganling Chongji in the treatment of patients with lower urinary tract infection. No adverse effect was found.
